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Updated: Jun 15, 2025

An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment
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基于生理学上的药理动力学 (PBPK) 建模的进展及其监管实用性,以支持口服药物产品的开发和协调

Yi-Hsien Cheng1, Sherin Thomas1, Yu Chung Tsang2

  • 1Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA.

Pharmaceutical research
|March 29, 2025
PubMed
概括

基于生理学上的药理动力学 (PBPK) 建模促进了口服药物开发,但在以患者为中心的标准和局部生物可用性验证方面面临挑战. 全球合作是监管协调的关键.

关键词:
统一化和化 统一化和化基于生理学的药理动力学 (PBPK) 吸收建模.虚拟生物等价性 (VBE) 是指

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